Sulfamethoxazole

根据《国家药监局关于发布药品说明书适老化及无障碍改革试点工作方案的公告》（2023年第142号），省级药品监管部门和国家药监局药品审评中心报送了参与试点的药品上市许可持有人和药品名单（第三批），现予公布。序号药品名称上市许可持有人1利伐沙班片天津力生制药股份有限公司2缬沙坦氨氯地平片（I）天津力生制药股份有限公司3呋塞米片天津力生制药股份有限公司4氢氯噻嗪片天津力生制药股份有限公司5盐酸普萘洛尔片天津力生制药股份有限公司6复方丹参滴丸天士力医药集团股份有限公司7养血清脑丸天士力医药集团股份有限公司8养血清脑颗粒天士力医药集团股份有限公司9盐酸二甲双胍片津药达仁堂集团股份有限公司新新制药厂10安宫牛黄丸津药达仁堂集团股份有限公司达仁堂制药厂11牛黄清心丸（局方）津药达仁堂集团股份有限公司达仁堂制药厂12大活络丸津药达仁堂集团股份有限公司达仁堂制药厂13清宫寿桃丸津药达仁堂集团股份有限公司达仁堂制药厂14包醛氧淀粉散天津太平洋制药有限公司15阿莫西林胶囊天津太平洋制药有限公司16包醛氧淀粉胶囊天津太平洋制药有限公司17吲达帕胺缓释胶囊天津太平洋制药有限公司18诺氟沙星胶囊天津太平洋制药有限公司19补肾通淋颗粒天津太平洋制药有限公司20牛磺酸颗粒天津太平洋制药有限公司21银黄颗粒天津太平洋制药有限公司22甲硝唑片天津太平洋制药有限公司23阿昔洛韦片天津太平洋制药有限公司24氨咖甘片天津太平洋制药有限公司25二羟丙茶碱片天津太平洋制药有限公司26非普拉宗片天津太平洋制药有限公司27格列本脲片天津太平洋制药有限公司28尼群地平片天津太平洋制药有限公司29羧甲司坦片天津太平洋制药有限公司30硝苯地平片天津太平洋制药有限公司31硝酸异山梨酯片天津太平洋制药有限公司32盐酸二甲双胍片天津太平洋制药有限公司33扎来普隆片天津太平洋制药有限公司34吲达帕胺片天津太平洋制药有限公司35利巴韦林片天津太平洋制药有限公司36复方磺胺甲噁唑片天津太平洋制药有限公司37谷维素片天津太平洋制药有限公司38醋酸氟轻松乳膏天津太平洋制药有限公司39丁酸氢化可的松乳膏天津太平洋制药有限公司40哈西奈德乳膏天津太平洋制药有限公司41健儿消食口服液天津和治药业集团有限公司42麦味地黄口服液天津和治药业集团有限公司43清喉咽合剂天津和治药业集团有限公司44清热解毒口服液天津和治药业集团有限公司45生脉饮天津和治药业集团有限公司46小儿咳喘灵口服液天津和治药业集团有限公司47小儿退热口服液天津和治药业集团有限公司48川贝止嗽合剂天津和治药业集团有限公司49消食健胃片天津和治药业集团有限公司50活力源片天津和治药业集团有限公司51四季感冒片天津和治药业集团有限公司52穿黄清热胶囊天津和治药业集团有限公司53血府逐瘀软胶囊天津和治药业集团有限公司54盐酸氟桂利嗪胶囊石家庄市华新药业有限责任公司55诺氟沙星胶囊石家庄市华新药业有限责任公司56盐酸二甲双胍缓释片石家庄市华新药业有限责任公司57吲达帕胺片石家庄市华新药业有限责任公司58盐酸左氧氟沙星片石家庄市华新药业有限责任公司59盐酸左氧氟沙星胶囊石家庄市华新药业有限责任公司60缬沙坦氨氯地平片（I）石家庄市华新药业有限责任公司61阿奇霉素干混悬剂石家庄市华新药业有限责任公司62阿奇霉素片石家庄市华新药业有限责任公司63硝酸甘油片石家庄市华新药业有限责任公司64伏格列波糖片石家庄市华新药业有限责任公司65头孢克肟干混悬剂石家庄市华新药业有限责任公司66菖麻熄风片黑龙江省济仁药业有限公司67参鹿茶黑龙江省济仁药业有限公司68前列闭尔通栓黑龙江省济仁药业有限公司69痹痛宁胶囊黑龙江乌苏里江制药有限公司哈尔滨分公司70氯诺昔康片黑龙江乌苏里江制药有限公司哈尔滨分公司71人参五味子颗粒黑龙江乌苏里江制药有限公司哈尔滨分公司72益脑宁片黑龙江新医圣制药有限责任公司73刺五加片黑龙江新医圣制药有限责任公司74宁神灵颗粒黑龙江新医圣制药有限责任公司75复方苦木消炎胶囊黑龙江新医圣制药有限责任公司76盐酸凯普拉生片江苏柯菲平医药股份有限公司77瑞维鲁胺片江苏恒瑞医药股份有限公司78羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司79番泻叶颗粒江苏艾迪药业股份有限公司80米氮平片华裕（无锡）制药有限公司81氨氯地平阿托伐他汀钙片昆山龙灯瑞迪制药有限公司82雷米普利片昆山龙灯瑞迪制药有限公司83尼麦角林片昆山龙灯瑞迪制药有限公司84云南白药膏云南白药集团无锡药业有限公司85云南白药创可贴云南白药集团无锡药业有限公司86盐酸氨基葡萄糖片江苏正大清江制药有限公司87厄贝沙坦氢氯噻嗪片江苏中治制药有限公司88阿哌沙班片南京正大天晴制药有限公司89芦比前列酮软胶囊南京正大天晴制药有限公司90奥美沙坦酯氨氯地平片江苏诺泰澳赛诺生物制药股份有限公司91噻托溴铵粉雾剂正大天晴药业集团股份有限公司92伏立康唑分散片扬子江药业集团南京海陵药业有限公司93左乙拉西坦片扬子江药业集团南京海陵药业有限公司94黄蜀葵花总黄酮口腔贴片杭州康恩贝制药有限公司95肾宝合剂浙江康恩贝中药有限公司96复方玄驹胶囊浙江施强制药有限公司97山海丹颗粒浙江施强制药有限公司98枸橼酸氢钾钠颗粒浙江施强制药有限公司99小儿咳喘灵口服液杭州华润老桐君药业有限公司100葡萄糖酸锌口服溶液杭州华润老桐君药业有限公司101百令胶囊杭州中美华东制药有限公司102泮托拉唑钠肠溶胶囊杭州中美华东制药有限公司103阿卡波糖片杭州中美华东制药有限公司104氨氯地平阿托伐他汀钙片瀚晖制药有限公司105海博麦布片浙江海正药业股份有限公司106盐酸多奈哌齐片浙江华海药业股份有限公司107草酸艾司西酞普兰片浙江华海药业股份有限公司108左乙拉西坦片浙江华海药业股份有限公司109奥氮平口崩片浙江华海药业股份有限公司110奥美沙坦酯氢氯噻嗪片浙江华海药业股份有限公司111阿立哌唑口崩片浙江华海药业股份有限公司112缬沙坦氢氯噻嗪片浙江华海药业股份有限公司113他达拉非片浙江华海药业股份有限公司114盐酸贝那普利片浙江华海药业股份有限公司115多巴丝肼片浙江华海药业股份有限公司116盐酸舍曲林片浙江华海药业股份有限公司117盐酸帕罗西汀片浙江华海药业股份有限公司118普瑞巴林胶囊浙江华海药业股份有限公司119赛洛多辛胶囊浙江华海药业股份有限公司120甲磺酸雷沙吉兰片浙江华海药业股份有限公司121福辛普利钠片浙江华海药业股份有限公司122利培酮片浙江华海药业股份有限公司123阿立哌唑片浙江华海药业股份有限公司124磷酸西格列汀片浙江华海药业股份有限公司125西格列汀二甲双胍片(II)浙江华海药业股份有限公司126硝苯地平控释片浙江华海药业股份有限公司127富马酸卢帕他定片浙江华海药业股份有限公司128维格列汀片浙江华海药业股份有限公司129恩格列净片浙江华海药业股份有限公司130托吡酯片浙江华海药业股份有限公司131沙库巴曲缬沙坦钠片浙江昂利康制药股份有限公司132头孢克洛颗粒浙江昂利康制药股份有限公司133盐酸左氧氟沙星片浙江昂利康制药股份有限公司134替格瑞洛片浙江昂利康制药股份有限公司135琥珀酸普芦卡必利片浙江昂利康制药股份有限公司136磷酸西格列汀片浙江昂利康制药股份有限公司137头孢氨苄胶囊浙江昂利康制药股份有限公司138聚卡波非钙片浙江昂利康制药股份有限公司139泊沙康唑肠溶片江西山香药业有限公司140甲苯磺酸索拉非尼片江西山香药业有限公司141醋酸阿比特龙片江西山香药业有限公司142艾司奥美拉唑镁肠溶片江西山香药业有限公司143盐酸坦索罗辛缓释胶囊江西山香药业有限公司144雷贝拉唑钠肠溶片江西山香药业有限公司145甲磺酸多沙唑嗪缓释片江西山香药业有限公司146甲磺酸仑伐替尼胶囊江西山香药业有限公司147马来酸阿法替尼片江西山香药业有限公司148哌柏西利胶囊江西山香药业有限公司149狗皮膏江西地康药业有限公司150海马万应膏江西地康药业有限公司151十全大补酒南昌恒湖药酒有限责任公司152人参药酒南昌恒湖药酒有限责任公司153枸杞药酒南昌恒湖药酒有限责任公司154周公百岁酒南昌恒湖药酒有限责任公司155史国公药酒南昌恒湖药酒有限责任公司156苯磺酸左氨氯地平片江西施美药业股份有限公司157辣椒风湿膏江西吉安三力制药有限公司158风茄平喘膏江西吉安三力制药有限公司159愈裂贴膏江西吉安三力制药有限公司160冻疮未溃膏江西吉安三力制药有限公司161伤疖膏江西吉安三力制药有限公司162曲安奈德新霉素贴膏江西吉安三力制药有限公司163恩替卡韦片江西制药有限责任公司164氟哌啶醇片江西制药有限责任公司165阿托伐他汀钙片江西制药有限责任公司166化积口服液江西诚志永丰药业有限责任公司167桔贝合剂江西诚志永丰药业有限责任公司168麻杏甘石合剂江西诚志永丰药业有限责任公司169鲜竹沥江西诚志永丰药业有限责任公司170生脉饮（党参方）江西诚志永丰药业有限责任公司171五子衍宗口服液江西诚志永丰药业有限责任公司172健儿清解液江西诚志永丰药业有限责任公司173肾宝合剂江西诚志永丰药业有限责任公司174清热解毒口服液江西诚志永丰药业有限责任公司175生脉饮江西诚志永丰药业有限责任公司176桂附地黄口服液江西诚志永丰药业有限责任公司177金钱通淋口服液江西诚志永丰药业有限责任公司178金果饮江西诚志永丰药业有限责任公司179麦味地黄口服液江西诚志永丰药业有限责任公司180杞菊地黄口服液江西诚志永丰药业有限责任公司181玉屏风口服液江西诚志永丰药业有限责任公司182四逆汤江西诚志永丰药业有限责任公司183小青龙合剂江西诚志永丰药业有限责任公司184他达拉非片南昌立健药业有限公司185枸橼酸西地那非片南昌立健药业有限公司186脑安滴丸安徽雷允上药业有限公司187脑安胶囊安徽雷允上药业有限公司188复方苁蓉益智胶囊安徽雷允上药业有限公司189再造生血胶囊安徽雷允上药业有限公司190再造生血片安徽雷允上药业有限公司191益气养血口服液安徽雷允上药业有限公司192黄厚止泻滴丸安徽雷允上药业有限公司193卡马西平片宜昌人福药业有限责任公司194维生素B2片宜昌人福药业有限责任公司195维生素B6片宜昌人福药业有限责任公司196非布司他片宜昌人福药业有限责任公司197琥珀酸美托洛尔缓释片宜昌人福药业有限责任公司198盐酸二甲双胍缓释片宜昌人福药业有限责任公司199萘普生钠片宜昌人福药业有限责任公司200枸橼酸托法替布缓释片宜昌人福药业有限责任公司201氨酚羟考酮片宜昌人福药业有限责任公司202盐酸羟考酮缓释片宜昌人福药业有限责任公司203奥卡西平片武汉人福药业有限责任公司204安立生坦片武汉人福药业有限责任公司205ω-3脂肪酸乙酯90软胶囊人福普克药业（武汉）有限公司206布洛芬软胶囊人福普克药业（武汉）有限公司207度他雄胺软胶囊人福普克药业（武汉）有限公司208艾地骨化醇软胶囊人福普克药业（武汉）有限公司209乙磺酸尼达尼布软胶囊人福普克药业（武汉）有限公司210甲硝唑片远大医药（中国）有限公司211他达拉非片远大医药（中国）有限公司212酒石酸美托洛尔片远大医药（中国）有限公司213磷酸奥司他韦颗粒宜昌东阳光长江药业股份有限公司214磷酸奥司他韦胶囊宜昌东阳光长江药业股份有限公司215替米沙坦片宜昌东阳光长江药业股份有限公司216替格瑞洛片宜昌东阳光长江药业股份有限公司217非布司他片宜昌东阳光长江药业股份有限公司218氟康唑胶囊宜昌东阳光长江药业股份有限公司219西格列汀二甲双胍片II宜昌东阳光长江药业股份有限公司220西格列汀二甲双胍片Ⅲ宜昌东阳光长江药业股份有限公司221磷酸奥司他韦干混悬剂宜昌东阳光长江药业股份有限公司222克拉霉素片宜昌东阳光长江药业股份有限公司223苯甲酸阿格列汀片宜昌东阳光长江药业股份有限公司224琥珀酸索利那新片宜昌东阳光长江药业股份有限公司225阿哌沙班片宜昌东阳光长江药业股份有限公司226七蕊胃舒胶囊健民药业集团股份有限公司227虚汗停糖浆健民药业集团股份有限公司228小儿紫贝宣肺糖浆健民药业集团股份有限公司229盐酸托莫西汀口服溶液健民药业集团股份有限公司230拉考沙胺口服溶液健民药业集团股份有限公司231硫酸特布他林健民药业集团股份有限公司232马来酸噻吗洛尔滴眼液武汉新瑞医药科技有限公司233溴芬酸钠滴眼液武汉五景药业有限公司234阿莫西林胶囊湖南科伦制药有限公司235康复新液湖南科伦制药有限公司236泊沙康唑口服混悬液湖南科伦制药有限公司237血塞通片湖南绅泰春制药股份有限公司238六味地黄丸（浓缩丸）九芝堂股份有限公司239杞菊地黄丸（浓缩丸）九芝堂股份有限公司240驴胶补血颗粒九芝堂股份有限公司241蒙脱石散江右制药（常德）有限公司242复方金银花颗粒江右制药（常德）有限公司243风热感冒颗粒江右制药（常德）有限公司244前列癃闭通片江右制药（常德）有限公司245复方雪莲烧伤膏江右制药（常德）有限公司246四消丸江右制药（常德）有限公司247阿胶山东喜君康医药集团湘潭有限公司248苯磺酸氨氯地平片湖南千金协力药业有限公司249恩替卡韦分散片湖南千金协力药业有限公司250硫酸氨基葡萄糖胶囊湖南先施制药有限公司251古汉养生精口服液古汉中药有限公司252古汉养生精片古汉中药有限公司253枸橼酸西地那非片广州朗圣药业有限公司254他达拉非片广州朗圣药业有限公司255双氯芬酸钠缓释片国药集团致君（深圳）坪山制药有限公司256奥美沙坦酯氨氯地平片国药集团致君（深圳）坪山制药有限公司257依托考昔片国药集团致君（深圳）制药有限公司258左乙拉西坦片深圳信立泰药业股份有限公司259左乙拉西坦缓释片深圳信立泰药业股份有限公司260艾司奥美拉唑镁肠溶胶囊广东东阳光药业股份有限公司261奥氮平口崩片广东东阳光药业股份有限公司262富马酸喹硫平片广东东阳光药业股份有限公司263奥美沙坦酯片东莞市阳之康医药有限责任公司264盐酸莫西沙星片东莞市阳之康医药有限责任公司265阿立哌唑口崩片东莞市阳之康医药有限责任公司266阿立哌唑片东莞市阳之康医药有限责任公司267草酸艾司西酞普兰片东莞市阳之康医药有限责任公司268盐酸度洛西汀肠溶胶囊东莞市阳之康医药有限责任公司269厄贝沙坦胶囊珠海润都制药股份有限公司270厄贝沙坦氢氯噻嗪片珠海润都制药股份有限公司271复方丹参片广州白云山和记黄埔中药有限公司272脑栓通胶囊广东华南药业集团有限公司273盐酸安非他酮缓释片万特制药（海南）有限公司274阿立哌唑口服溶液万特制药（海南）有限公司275盐酸莫西沙星片重庆华邦制药有限公司276利伐沙班片重庆华邦制药有限公司277苯磺贝他斯汀片重庆华邦制药有限公司278萘替芬酮康唑乳膏重庆华邦制药有限公司279维A酸乳膏重庆华邦制药有限公司280盐酸左西替利嗪口服溶液重庆华邦制药有限公司281盐酸左西替利嗪片重庆华邦制药有限公司282阿伐斯汀胶囊重庆华邦制药有限公司283阿维A胶囊重庆华邦胜凯制药有限公司284异维A酸软胶囊重庆华邦胜凯制药有限公司285地奈德乳膏重庆华邦胜凯制药有限公司286甘桔冰梅片重庆华森制药股份有限公司287痛泻宁颗粒重庆华森制药股份有限公司288都梁软胶囊重庆华森制药股份有限公司289八味芪龙颗粒重庆华森制药股份有限公司290铝碳酸镁片重庆华森制药股份有限公司291铝碳酸镁咀嚼片重庆华森制药股份有限公司292奥美拉唑碳酸氢钠胶囊重庆华森制药股份有限公司293奥美沙坦酯氨氯地平片重庆华森制药股份有限公司294小金片太极集团重庆桐君阁药厂有限公司295苏合香丸太极集团重庆桐君阁药厂有限公司296沉香化气片太极集团重庆桐君阁药厂有限公司297强力天麻杜仲丸太极集团重庆桐君阁药厂有限公司298麻仁丸太极集团重庆桐君阁药厂有限公司299安宫牛黄丸太极集团重庆桐君阁药厂有限公司300还少丹（大蜜丸）太极集团重庆桐君阁药厂有限公司301还少丹太极集团重庆桐君阁药厂有限公司302归脾合剂太极集团重庆桐君阁药厂有限公司303桔贝合剂太极集团重庆桐君阁药厂有限公司304拨云退翳丸太极集团重庆桐君阁药厂有限公司305藿香正气口服液太极集团重庆涪陵制药厂有限公司306通天口服液太极集团重庆涪陵制药厂有限公司307急支糖浆太极集团重庆涪陵制药厂有限公司308急支颗粒太极集团重庆涪陵制药厂有限公司309补肾益寿胶囊太极集团重庆涪陵制药厂有限公司310丹参口服液太极集团重庆涪陵制药厂有限公司311盐酸文拉法辛片重庆药友制药有限责任公司312吲达帕胺片重庆药友制药有限责任公司313复方对乙酰氨基酚片（II）西南药业股份有限公司314布洛芬缓释片西南药业股份有限公司315维生素C咀嚼片西南药业股份有限公司316左氧氟沙星片四川新斯顿制药股份有限公司317塞来昔布胶囊四川新斯顿制药股份有限公司318盐酸氨基葡萄糖片四川新斯顿制药股份有限公司319苯酰甲硝唑分散片四川新斯顿制药股份有限公司320氯雷他定口腔崩解片四川新斯顿制药股份有限公司321盐酸美金刚片四川新斯顿制药股份有限公司322左氧氟沙星滴眼液四川美大康华康药业有限公司323盐酸莫西沙星滴眼液四川美大康华康药业有限公司324伏立康唑片四川美大康华康药业有限公司325来那度胺胶囊四川美大康华康药业有限公司326普乐安片云南白药集团股份有限公司327藿香正气胶囊云南白药集团股份有限公司328复方丹参片云南白药集团股份有限公司329六味地黄胶囊云南白药集团股份有限公司330关节止痛膏云南白药集团股份有限公司331伤湿止痛膏云南白药集团股份有限公司332麝香跌打风湿膏云南白药集团股份有限公司333一枝蒿伤湿祛痛膏云南白药集团股份有限公司334参苓健脾胃颗粒云南白药集团股份有限公司335宫血宁胶囊云南白药集团股份有限公司336痛舒胶囊云南白药集团股份有限公司337三七参蜂口服液云南白药集团股份有限公司338伤风停胶囊云南白药集团股份有限公司339丹溪玉屏风颗粒云南白药集团股份有限公司340风热感冒颗粒云南白药集团股份有限公司341四季感冒片云南白药集团股份有限公司342妇炎康片云南白药集团股份有限公司343痛舒片云南白药集团股份有限公司344消炎退热颗粒云南白药集团股份有限公司345板蓝根颗粒云南白药集团股份有限公司346热毒清片云南白药集团股份有限公司347玄麦甘桔颗粒云南白药集团股份有限公司348天紫红女金胶囊云南白药集团股份有限公司349小儿健脾平肝颗粒云南白药集团股份有限公司350小儿七星茶颗粒云南白药集团股份有限公司351止泻保童颗粒云南白药集团股份有限公司352泻痢消胶囊云南白药集团股份有限公司353生脉饮（党参方）云南白药集团股份有限公司354肿痛气雾剂云南白药集团股份有限公司355伤益气雾剂云南白药集团股份有限公司356利儿康口服液云南白药集团股份有限公司357陈香露白露片云南白药集团大理药业有限责任公司358气血康口服液云南白药集团文山七花有限责任公司359血塞通软胶囊昆药集团股份有限公司360血塞通片云南维和药业股份有限公司361血塞通胶囊云南维和药业股份有限公司362血塞通颗粒云南维和药业股份有限公司363盐酸莫西沙星片Bayer Vital GmbH364屈螺酮炔雌醇片Bayer Australia Ltd365琥珀酸索利那新片Astellas Pharma Europe B.V.366盐酸普拉克索片Boehringer Ingelheim International GmbH367达比加群酯胶囊Boehringer Ingelheim International GmbH368盐酸普拉克索缓释片Boehringer Ingelheim International GmbH369马来酸阿法替尼片Boehringer Ingelheim International GmbH

Primary and secondary objectives were met in the open-label randomized Part 1 of the clinical trial to treat uncomplicated UTIs caused by antibiotic-resistant E. coli Dosing has begun in Part 2, the controlled, double-blind portion of the trial triggered by the success in Part 1 Data support potential of Locus’ engineered bacteriophage platform in combatting the global health crisis of infections caused by multidrug-resistant (MDR) pathogens RESEARCH TRIANGLE PARK, N.C., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Locus Biosciences, Inc. (“Locus”), a clinical-stage biotechnology company developing a new class of precision engineered bacteriophage treatments for a diverse set of bacterial diseases, today announced positive results from Part 1 of its two-part Phase 2 ELIMINATE trial. This Phase 2 trial is evaluating LBP-EC01, a CRISPR-Cas3 genetically engineered bacteriophage therapy designed to treat patients with uncomplicated urinary tract infections (uUTIs) caused by antimicrobial-resistant (AMR) and multi-drug-resistant (MDR) Escherichia coli (E. coli). Data from the randomized, uncontrolled, open-label Part 1 portion of the trial were published in The Lancet Infectious Diseases. Locus also announced that dosing has begun in the randomized, controlled, and blinded Part 2 portion of this Phase 2 study. This clinical trial is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Worldwide, an estimated 150 million people are affected by UTIs each year. Approximately 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics. Up to 40% of UTI patients experience a recurrence, often within months of the first episode. Both the U.S. Centers for Disease Control and Prevention and the World Health Organization have identified antibiotic-resistant E. coli as an urgent and serious public health threat requiring the development of new treatments. Part 1 of ELIMINATE enrolled 39 adult female patients, across six United States-based clinical centers and had an overall objective of defining a dosing regimen of LBP-EC01 and oral trimethoprim/sulfamethoxazole (TMP/SMX) to advance to Part 2 of the trial. This overall objective was supported by analysis of the primary outcome of pharmacokinetics (PK) in urine and blood, and the secondary outcome of safety, which were assessed on randomized patients dosed at least once with LBP-EC01. In addition, an exploratory outcome of pharmacodynamic (PD) assessments was performed on 16 evaluable patients. “The need for new targeted antibacterial therapies is urgent given the increasing impact of antibiotic-resistant pathogens, which we see in our clinic every day,” said Juvenal E. Martinez, M.D., an investigator in the trial. “As the first Phase 2 engineered bacteriophage trial, ELIMINATE is breaking new ground in the quest to address increasingly prevalent serious MDR infections. This encouraging initial data support the possible utility of bacteriophages and the potential of LBP-EC01 as a therapeutic option to address drug-resistant bacterial infections, such as UTIs, which have a high recurrence rate due to MDR pathogens.” ELIMINATE Trial Part 1 Results The primary and secondary outcomes of Part 1 were met, and a dosing regimen was identified that was well-tolerated and which led to high drug exposure at the site of infection. No serious adverse events were observed in Part 1, and exposure to LBP-EC01 did not lead to any observations of genetic resistance in any subsequently recovered E. coli samples. Part 1 was initiated with three treatment groups focused on intravenous (IV) delivery of a high 1×1011 plaque forming units (PFU)/dose of LBP-EC01 which was halted after three patients discontinued dosing due to non-serious adverse events of mild tachycardia and afebrile chills. Three updated treatment groups, which focused on a short, 3-day course of intra-urethral (i.e., IU or direct to bladder) and lower exposure IV dosing, replaced the original treatment groups. With this updated dosing approach, a rapid reduction of E. coli in urine was observed four hours after the first treatment which was maintained to the day 10 test of cure (TOC) evaluation. All (16 of 16) patients in the evaluable population had complete resolution of UTI symptoms and 14 of 16 (87.5%) patients demonstrated microbiologic cure or reduction of their bacterial infection below 1×103 colony forming units (CFU)/mL in urine by the day 10 TOC. A dosing regimen of LBP-EC01 given for 2 days IU (2×1012 PFU/dose) and given concurrently for 3 days IV (1×1010 PFU/dose) with concomitant oral TMP/SMX (160 mg TMP/800 mg SMX twice daily) has been advanced into Part 2. ELIMINATE Trial Part 2 underway Part 2 of the ELIMINATE trial has been initiated with patient dosing underway. This randomized, controlled, double-blind portion of the trial will evaluate the efficacy, safety, tolerability, and pharmacokinetics of LBP-EC01 with TMP/SMX. Up to 288 female uncomplicated UTI patients will be enrolled and randomized in a 1:1 ratio where patients will receive LBP-EC01 or placebo for the 3-day dosing regimen selected from Part 1. The primary objective will be to evaluate the effect of LBP-EC01 given with TMP/SMX on its ability to treat acute UTIs in patients with a history of UTI recurrence. The impact of the treatment on reducing UTI recurrence and/or extending the duration of time to the next UTI recurrence will be examined as an exploratory endpoint in a 6-month follow-up evaluation. This trial is registered with ClinicalTrials.gov, NCT05488340, and is ongoing. “These milestones represent a huge step forward in the critical fight against MDR. Over the past eight years, we have invested significant resources to build the Locus engineered bacteriophage platform. We developed our high-throughput robotics and AI technology to optimize a fixed set of precisely engineered phages that target over 95 percent of current uropathogenic E. coli strains, including MDR strains. We also built a world-class viral vector manufacturing facility that produces GMP materials at potency and purity levels higher than any others we have seen in the field to date. These Part 1 data validate our platform and support the advancement of a potential first-in-class therapy,” said Paul Garofolo, Co-founder and CEO of Locus. “We are grateful for the participating sites, clinicians, and patients, and our funding partner BARDA. We are eager to build on this positive momentum as we continue Part 2 of the ELIMINATE trial.” For more information on Part 1 of the ELIMINATE trial, visit clinicaltrials.gov using the identifier NCT05488340. Patients interested in participating in Part 2 can visit www.eliminateuti.com. About LBP-EC01LBP-EC01 is a CRISPR-enhanced bacteriophage therapy in development for the treatment of urinary tract infections and other infections caused by the pathogen E. coli. It is a bacteriophage cocktail engineered with a CRISPR-Cas3 construct targeting the E. coli genome. The precision medicine product works through a unique dual mechanism of action utilizing both the natural lytic activity of the bacteriophage along with the DNA-targeting activity of CRISPR-Cas3. LBP-EC01 previously met all primary and secondary endpoints and demonstrated safety and tolerability in a Phase 1b trial. LBP-EC01 is currently being evaluated in a Phase 2 trial for the treatment of UTIs caused by E. coli. In 2020, Locus and BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), announced an agreement to co-fund development of LBP-EC01. Under the partnership agreement, contract number 75A50120C00169, BARDA will provide up to $93 million to Locus as part of a $152 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. Food and Drug Administration (FDA) for LBP-EC01. About Locus BiosciencesLocus Biosciences is creating a new class of precision biotherapeutics with clinical-stage engineered bacteriophage treatments for a diverse set of bacterial and microbiome/inflammatory diseases. A world-leading bacteriophage discovery, synthetic biology, and manufacturing platform powers the company. Locus engineers bacteriophage - naturally occurring viruses that target bacteria - to kill pathogenic bacteria, while sparing good bacteria, through programmable precision anti-bacterials with CRISPR-Cas3 and other therapeutic payloads. Its artificial intelligence and machine-learning based discovery engine targets bacteria that are associated with disease across multiple therapeutic areas including infectious disease, immunology, and oncology. Locus has secured multiple non-dilutive partnerships to support development of the company’s platform and programs. These include anti-bacterial partnerships with Biomedical Advanced Research and Development Authority (BARDA) for its lead asset targeting E. coli and Combatting Antibiotic Resistant Bacteria Accelerator (CARB-X) for its asset targeting K. pneumoniae. For more on the Research Triangle Park, N.C.-based company, visit www.locus-bio.com. Media Contact:Gina Mangiaracina6 Degrees gmangiaracina@6degreespr.com